A Phase 2 interventional study of Antidepressant + SPD489 (lisdexamfetamine dimesylate) and Antidepressant + placebo in Major Depressive Disorder, sponsored by Shire. Completed at 15 sites in United States. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2021-06-14.
Sponsored by Shire · Phase 2, Interventional, and Treatment
To evaluate the efficacy of SPD489 when used as augmentation to an antidepressant in the treatment of major depressive disorder (MDD) as measured by mean change in total Montgomery-Ǻsberg Depression Rating Scale (MADRS) scores.
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This study's enrollment of 246 is above the median of 80 across 3,999 interventional studies indexed under Depressive Disorder.
Browse Depressive Disorder studies →Shire is the lead sponsor of 346 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
Antidepressant + SPD489
Drug: Antidepressant + SPD489 (lisdexamfetamine dimesylate)
Antidepressant + placebo
Drug: Antidepressant + placebo
Escitalopram oxalate (antidepressant) 20 mg/day oral + 20, 30, or 50 mg SPD489 oral once daily for 6 weeks
Also known as: LDX, Vyvanse
Escitalopram oxalate (antidepressant) 20 mg/day oral + placebo oral once daily for 6 weeks
Change From Augmentation Baseline for Non-Remitters in Montgomery-Ǻsberg Depression Rating Scale (MADRS) Total Score at Week 6 - Last Observation Carried Forward (LOCF)
MADRS is a validated, 10-item rating scale with each item being scored on a scale from 0-6 with a total score ranging from 0-60. Lower scores indicate a decreased severity of depression.
Time frame: Augmentation Baseline, 6 weeks
Change From Augmentation Baseline for Non-Remitters in the Hamilton Depression Scale (HAM-D) Total Score at Week 6 - LOCF
The HAM-D is a validated rating scale which consists of 17 items. Nine of the items are scored on a scale of 0-4 and 8 items are scored on a scale of 0-2 for a total scoring range of 0-52. A score of 0-7 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher indicates increased severity of depression. In general, the lower the total score the less severe the depression.
Time frame: Augmentation Baseline, 6 weeks
Change From Augmentation Baseline for Non-Remitters in the Sheehan Disability Scale (SDS) Total Score at Week 6
Designed to evaluate the extent to which illness symptoms impact a subject's life in 3 areas: work/school, social, and family/home. Each area is scored on a scale from 0 (no impairment) to 10 (highly impaired) with a total score ranging from 0 (unimpaired) to 30 (highly impaired). Lower scores translate into less impairment.
Time frame: Augmentation Baseline, 6 weeks
Percentage of Non-Remitters With Improvement on Clinical Global Impression-Improvement (CGI-I) at Week 6 - LOCF
Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.
Time frame: 6 weeks
Assessment in Non-Remitters of Clinical Global Impression-Severity of Illness (CGI-S) at Augmentation Baseline
CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)
Time frame: Augmentation baseline
Assessment in Non-Remitters of Clinical Global Impression-Severity of Illness (CGI-S) at Week 6
CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)
Time frame: 6 weeks
Change From Augmentation Baseline for Non-Remitters in the Behavior Rating Inventory of Executive Function - Adult Version (BRIEF-A) Scale Total Score at Week 6
BRIEF-A is a validated 75-item questionnaire composed of three scales (Global Executive Composite, Behavioral Recognition Index, and Metacognition Index). Items are rated 1 (never), 2 (sometimes), and 3 (often). There is no range for a total score. Raw scale scores are used to develop interpretive reports. Lower scores reflect better functioning.
Time frame: Augmentation Baseline and 6 weeks
Change From Augmentation Baseline for Non-Remitters in the Multidimensional Assessment of Fatigue (MAF) Scale Total Score at Week 6
MAF contains 16 items scored on a scale from 1 (not at all) to 10 (a great deal). Answers are converted to a Global Fatigue Index with total scores ranging from 1 (no fatigue) to 50 (severe fatigue). Lower scores indicate less fatigue.
Time frame: Augmentation Baseline and 6 weeks
Change From Augmentation Baseline for Non-Remitters in the Quick Inventory of Depressive Symptomatology - Self-Report (QIDS-SR) Scale Total Score at Week 6
QIDS-SR is a validated, self-reported rating scale that contains 16 items scored on a scale from 0-3 with total scores ranging from 0 (no depression) to 27 (very severe depression). Lower scores indicate less depression.
Time frame: Augmentation Baseline and 6 weeks
Change From Augmentation Baseline for Remitters in MADRS Total Score at Week 6 - LOCF
MADRS is a validated, 10-item rating scale with each item being scored on a scale from 0-6 with a total score ranging from 0-60. Lower scores indicate a decreased severity of depression.
Time frame: Augmentation Baseline and 6 weeks
Change From Augmentation Baseline for Remitters in the HAM-D Total Score at Week 6 - LOCF
The HAM-D is a validated rating scale which consists of 17 items. Nine of the items are scored on a scale of 0-4 and 8 items are scored on a scale of 0-2 for a total scoring range of 0-52. A score of 0-7 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher indicates increased severity of depression. In general, the lower the total score the less severe the depression.
Time frame: Augmentation Baseline and 6 weeks
Change From Augmentation Baseline for Remitters in the SDS Total Score at Week 6
Designed to evaluate the extent to which illness symptoms impact a subject's life in 3 areas: work/school, social, and family/home. Each area is scored on a scale from 0 (no impairment) to 10 (highly impaired) with a total score ranging from 0 (unimpaired) to 30 (highly impaired). Lower scores translate into less impairment.
Time frame: Augmentation Baseline and 6 weeks
Percentage of Remitters With Improvement on CGI-I at Week 6 - LOCF
Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.
Time frame: 6 weeks
Assessment in Remitters of CGI-S at Augmentation Baseline
CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)
Time frame: Augmentation Baseline
Assessment in Remitters of CGI-S at Week 6
CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)
Time frame: 6 weeks
Change From Augmentation Baseline for Remitters in the BRIEF-A Scale Total Score at Week 6
BRIEF-A is a validated 86-item questionnaire composed of three scales (Global Executive Composite, Behavioral Recognition Index, and Metacognition Index). Items are rated 1 (never), 2 (sometimes), and 3 (often). Lower scores reflect better functioning.
Time frame: Augmentation baseline and 6 weeks
Change From Augmentation Baseline for Remitters in the MAF Scale Total Score at Week 6
MAF contains 16 items scored on a scale from 1 (not at all) to 10 (a great deal). Answers are converted to a Global Fatigue Index with total scores ranging from 1 (no fatigue) to 50 (severe fatigue). Lower scores indicate less fatigue.
Time frame: Augmentation baseline and 6 weeks
Change From Augmentation Baseline for Remitters in the QIDS-SR Scale Total Score at Week 6
QIDS-SR is a validated, self-reported rating scale that contains 16 items scored on a scale from 0-3 with total scores ranging from 0 (no depression) to 27 (very severe depression). Lower scores indicate less depression.
Time frame: Augmentation baseline and 6 weeks
| Milestone | Antidepressant + SPD489 | Antidepressant + Placebo . |
|---|---|---|
| Started | 89 | 88 |
| Completed | 78 | 79 |
| Not completed | 11 | 9 |
| Withdrew: Lost to follow-up | 3 | 3 |
| Withdrew: Withdrawal by subject | 1 | 2 |
| Withdrew: Adverse event | 4 | 2 |
| Withdrew: Non-compliance with study medication | 2 | 0 |
| Withdrew: Sponsor decision | 1 | 0 |
| Withdrew: Positive urine drug screen | 0 | 1 |
| Withdrew: Non-adherence to visit schedule | 0 | 1 |
MADRS is a validated, 10-item rating scale with each item being scored on a scale from 0-6 with a total score ranging from 0-60. Lower scores indicate a decreased severity of depression.
| Units on a scale | Antidepressant + SPD489 (Non-remitters) | Antidepressant + Placebo (Non-remitters) |
|---|---|---|
| Change From Augmentation Baseline for Non-Remitters in Montgomery-Ǻsberg Depression Rating Scale (MADRS) Total Score at Week 6 - Last Observation Carried Forward (LOCF) | -7.1 ± 0.93 | -4.9 ± 0.94 |
The HAM-D is a validated rating scale which consists of 17 items. Nine of the items are scored on a scale of 0-4 and 8 items are scored on a scale of 0-2 for a total scoring range of 0-52. A score of 0-7 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher indicates increased severity of depression. In general, the lower the total score the less severe the depression.
| Units on a scale | Antidepressant + SPD489 (Non-remitters) | Antidepressant + Placebo (Non-remitters) |
|---|---|---|
| Change From Augmentation Baseline for Non-Remitters in the Hamilton Depression Scale (HAM-D) Total Score at Week 6 - LOCF | -4.9 ± 0.64 | -4.0 ± 0.65 |
Designed to evaluate the extent to which illness symptoms impact a subject's life in 3 areas: work/school, social, and family/home. Each area is scored on a scale from 0 (no impairment) to 10 (highly impaired) with a total score ranging from 0 (unimpaired) to 30 (highly impaired). Lower scores translate into less impairment.
| Units on a scale | Antidepressant + SPD489 (Non-remitters) | Antidepressant + Placebo (Non-remitters) |
|---|---|---|
| Change From Augmentation Baseline for Non-Remitters in the Sheehan Disability Scale (SDS) Total Score at Week 6 | -3.7 ± 0.73 | -1.7 ± 0.74 |
Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.
| Percent of Participants | Antidepressant + SPD489 (Non-remitters) | Antidepressant + Placebo (Non-remitters) |
|---|---|---|
| Percentage of Non-Remitters With Improvement on Clinical Global Impression-Improvement (CGI-I) at Week 6 - LOCF | 60.0 | 45.3 |
CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)
| Percent of participants | Antidepressant + SPD489 (Non-remitters) | Antidepressant + Placebo (Non-remitters) |
|---|---|---|
| Normal, not at all ill | 1.5 | 1.6 |
| Borderline mentally ill | 20.0 | 12.5 |
| Mildly ill | 40.0 | 34.4 |
| Moderately ill | 32.3 | 48.4 |
| Markedly ill | 6.2 | 3.1 |
| Severely ill | 0 | 0 |
| Among the most extremely ill | 0 | 0 |
CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)
| Percent of participants | Antidepressant + SPD489 (Non-remitters) | Antidepressant + Placebo (Non-remitters) |
|---|---|---|
| Normal, not at all ill | 27.0 | 14.5 |
| Borderline mentally ill | 31.7 | 24.2 |
| Mildly ill | 30.2 | 22.6 |
| Moderately ill | 9.5 | 29.0 |
| Markedly ill | 1.6 | 9.7 |
| Severely ill | 0 | 0 |
| Among the most extremely ill | 0 | 0 |
BRIEF-A is a validated 75-item questionnaire composed of three scales (Global Executive Composite, Behavioral Recognition Index, and Metacognition Index). Items are rated 1 (never), 2 (sometimes), and 3 (often). There is no range for a total score. Raw scale scores are used to develop interpretive reports. Lower scores reflect better functioning.
| Units on a scale | Antidepressant + SPD489 (Non-remitters) | Antidepressant + Placebo (Non-remitters) |
|---|---|---|
| Global Executive Composite | -4.7 ± 1.03 | -1.7 ± 1.04 |
| Behavioral Regulation Index | -3.7 ± 0.97 | -1.7 ± 0.99 |
| Metacognition Index | -4.8 ± 1.04 | -1.5 ± 1.06 |
MAF contains 16 items scored on a scale from 1 (not at all) to 10 (a great deal). Answers are converted to a Global Fatigue Index with total scores ranging from 1 (no fatigue) to 50 (severe fatigue). Lower scores indicate less fatigue.
| Units on a scale | Antidepressant + SPD489 (Non-remitters) | Antidepressant + Placebo (Non-remitters) |
|---|---|---|
| Change From Augmentation Baseline for Non-Remitters in the Multidimensional Assessment of Fatigue (MAF) Scale Total Score at Week 6 | -5.3 ± 1.25 | -2.3 ± 1.26 |
QIDS-SR is a validated, self-reported rating scale that contains 16 items scored on a scale from 0-3 with total scores ranging from 0 (no depression) to 27 (very severe depression). Lower scores indicate less depression.
| Units on a scale | Antidepressant + SPD489 (Non-remitters) | Antidepressant + Placebo (Non-remitters) |
|---|---|---|
| Change From Augmentation Baseline for Non-Remitters in the Quick Inventory of Depressive Symptomatology - Self-Report (QIDS-SR) Scale Total Score at Week 6 | -2.4 ± 0.45 | -1.2 ± 0.46 |
MADRS is a validated, 10-item rating scale with each item being scored on a scale from 0-6 with a total score ranging from 0-60. Lower scores indicate a decreased severity of depression.
| Units on a scale | Antidepressant + SPD489 (Remitters) | Antidepressant + Placebo (Remitters) |
|---|---|---|
| Change From Augmentation Baseline for Remitters in MADRS Total Score at Week 6 - LOCF | 0.1 ± 1.13 | -1.1 ± 1.18 |
The HAM-D is a validated rating scale which consists of 17 items. Nine of the items are scored on a scale of 0-4 and 8 items are scored on a scale of 0-2 for a total scoring range of 0-52. A score of 0-7 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher indicates increased severity of depression. In general, the lower the total score the less severe the depression.
| Units on a scale | Antidepressant + SPD489 (Remitters) | Antidepressant + Placebo (Remitters) |
|---|---|---|
| Change From Augmentation Baseline for Remitters in the HAM-D Total Score at Week 6 - LOCF | -0.8 ± 0.92 | -1.6 ± 0.96 |
Designed to evaluate the extent to which illness symptoms impact a subject's life in 3 areas: work/school, social, and family/home. Each area is scored on a scale from 0 (no impairment) to 10 (highly impaired) with a total score ranging from 0 (unimpaired) to 30 (highly impaired). Lower scores translate into less impairment.
| Units on a scale | Antidepressant + SPD489 (Remitters) | Antidepressant + Placebo (Remitters) |
|---|---|---|
| Change From Augmentation Baseline for Remitters in the SDS Total Score at Week 6 | -1.6 ± 0.89 | -0.6 ± 0.91 |
Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.
| Percent of participants | Antidepressant + SPD489 (Remitters) | Antidepressant + Placebo (Remitters) |
|---|---|---|
| Percentage of Remitters With Improvement on CGI-I at Week 6 - LOCF | 65.2 | 52.4 |
CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)
| Percent of participants | Antidepressant + SPD489 (Remitters) | Antidepressant + Placebo (Remitters) |
|---|---|---|
| Normal, not at all ill | 26.1 | 23.8 |
| Borderline mentally ill | 47.8 | 71.4 |
| Mildly ill | 21.7 | 4.8 |
| Moderately ill | 4.3 | 0 |
| Markedly ill | 0 | 0 |
| Severely ill | 0 | 0 |
| Among the most extremely ill | 0 | 0 |
CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)
| Percent of participants | Antidepressant + SPD489 (Remitters) | Antidepressant + Placebo (Remitters) |
|---|---|---|
| Normal, not at all ill | 50.0 | 61.9 |
| Borderline mentally ill | 36.4 | 23.8 |
| Mildly ill | 13.6 | 9.5 |
| Moderately ill | 0 | 4.8 |
| Markedly ill | 0 | 0 |
| Severely ill | 0 | 0 |
| Among the most extremely ill | 0 | 0 |
BRIEF-A is a validated 86-item questionnaire composed of three scales (Global Executive Composite, Behavioral Recognition Index, and Metacognition Index). Items are rated 1 (never), 2 (sometimes), and 3 (often). Lower scores reflect better functioning.
| Units on a scale | Antidepressant + SPD489 (Remitters) | Antidepressant + Placebo (Remitters) |
|---|---|---|
| Global Executive Composite | -0.9 ± 1.21 | -2.7 ± 1.21 |
| Behavioral Regulation Index | -0.4 ± 1.37 | -1.5 ± 1.37 |
| Metacognition Index | -1.1 ± 1.24 | -3.4 ± 1.24 |
MAF contains 16 items scored on a scale from 1 (not at all) to 10 (a great deal). Answers are converted to a Global Fatigue Index with total scores ranging from 1 (no fatigue) to 50 (severe fatigue). Lower scores indicate less fatigue.
| Units on a scale | Antidepressant + SPD489 (Remitters) | Antidepressant + Placebo (Remitters) |
|---|---|---|
| Change From Augmentation Baseline for Remitters in the MAF Scale Total Score at Week 6 | -4.0 ± 1.77 | -0.2 ± 1.81 |
QIDS-SR is a validated, self-reported rating scale that contains 16 items scored on a scale from 0-3 with total scores ranging from 0 (no depression) to 27 (very severe depression). Lower scores indicate less depression.
| Units on a scale | Antidepressant + SPD489 (Remitters) | Antidepressant + Placebo (Remitters) |
|---|---|---|
| Change From Augmentation Baseline for Remitters in the QIDS-SR Scale Total Score at Week 6 | -1.9 ± 0.57 | -0.4 ± 0.58 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Antidepressant + SPD489 | — | 0/88 (0%) | 35/88 (39.8%) |
| Antidepressant + Placebo . | — | 1/85 (1.2%) | 15/85 (17.6%) |
| Event | Antidepressant + SPD489 | Antidepressant + Placebo . |
|---|---|---|
| RhabdomyolysisMusculoskeletal and connective tissue disorders | 0/88 | 1/85 |
| Event | Antidepressant + SPD489 | Antidepressant + Placebo . |
|---|---|---|
| Dry mouthGastrointestinal disorders | 10/88 | 0/85 |
| HeadacheNervous system disorders | 10/88 | 4/85 |
| InsomniaPsychiatric disorders | 4/88 | 6/85 |
| Decreased appetiteMetabolism and nutrition disorders | 6/88 | 2/85 |
| NasopharyngitisInfections and infestations | 5/88 | 3/85 |
| Age, Continuous(years) | Antidepressant + SPD489 | Antidepressant + Placebo . | Total |
|---|---|---|---|
| Mean | 39.4 ± 9.65 | 38.6 ± 10.38 | 39.0 ± 9.99 |
| Age, Customized(Participants) | Antidepressant + SPD489 | Antidepressant + Placebo . | Total |
|---|---|---|---|
| 18-40 years | 44 | 49 | 93 |
| 41-55 years | 44 | 36 | 80 |
| Sex: Female, Male(Participants) | Antidepressant + SPD489 | Antidepressant + Placebo . | Total |
|---|---|---|---|
| Female | 53 | 54 | 107 |
| Male | 35 | 31 | 66 |
| Region of Enrollment(Participants) | Antidepressant + SPD489 | Antidepressant + Placebo . | Total |
|---|---|---|---|
| United States | 88 | 85 | 173 |
This study is completed, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.
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